MGE are part way through the process of developing a new state of the art wearable monitoring device to assist Clinicians and Patients in the monitoring of blood flow through Arteriovenous Fistulas, used in Haemodialysis by patients suffering from chronic kidney disease (CKD) or end stage renal disease (ESRD).

Current methods of monitoring involve the use of larger items of expensive equipment giving one off readings making monitoring assessments costly and restricted.

This page details the current status of the AVF project and future plans for the device

If you would like further information, please contact us

AVF devices with Probe and wriststrap 2_edited.jpg

Project Phase 1 - Complete

Phase 1 of the Project concerned the proving of the technical concept of the device and its functionality and producing a prototype device. This was a 3 year project working with Anglia Ruskin University in Chelmsford and supported by a Grant from Innovate UK, part of UK Research and Innovation (UKRI).

Background

End stage renal disease (ESRD) in the UK is estimated at around 500 cases per million people and around 20% of cases progress to dialysis each year. It is estimated that these figures will double by 2030. Current Medical opinion is that the best and most efficient method of providing haemodialysis is by creating an arteriovenous fistula (AVF) and circulating the blood through there.

However, the process for creating an AVF on a patient takes around 6 weeks and has a high failure rate (30-40%). Even once successfully created, fistulas will deteriorate over time resulting in longer dialysis times for the patient as flow rates drop and eventual failure, meaning further surgery at that point. The medical reasons for what cause fistulas to fail are still fairly unknow and whilst several current strategies revolve around the stents or other invasive medical devices, it has been shown in Studies that an alternative approach is by frequent monitoring of the blood flow through the fistula. In this way, problems can be identified early, and plans made to circumvent them.

Currently, monitoring of flow can only be done by a combination of Doppler ultrasound \ ultrasound dilution (or using other large expensive machinery). This requires the patient to attend a hospital appointment and is a one-off reading, so is limited in its effectiveness, costly and time intensive for both clinician and patient.

The aim of Phase 1 of the project was to design and test a prototype, wearable, non-invasive monitoring system utilising our new patented technologies to demonstrate that it could successfully monitor the status of a patients' arteriovenous fistula (AVF) and eventually lead to real time monitoring and early identification of any issues either with the maturation of the AVF (prior to dialysis) or throughout its lifespan (during the dialysis process). This is a key benefit as early identification of issues will result in better patient management leading to financial savings and better use of dialysis equipment & personnel as potential problems can then be planned around in advance. It also ultimately will improve the quality of life for the patient.

Device Data gathering presentation

Project Phase 2 -In Planning

We are now planning the 2nd phase of the project and are currently in discussion with several partners. This phase of the project will build on the findings and outputs of Phase 1 with the aim of producing a final commercialised device which has been clinically tested and medically approved.

The project will be split into several work packages based on the following 3 areas:

Technical Development & Engineering

Reduction of the current prototype device’s cost, size, and power consumption through value engineering, integrated PCB design, and optimised component selection, ensuring affordability for large-scale NHS deployment and further enhancement and validation of the developed algorithms.

Clinical Validation & Evidence Generation

Clinically validate the improved device in real-world haemodialysis settings, assessing accuracy, sensitivity, and specificity for detecting early AV fistula stenosis, thrombosis, and infection compared with gold-standard clinical assessments and Doppler ultrasound. This will be done in a single or multi-centre clinical study, assessing reliability, patient acceptability, and integration into routine dialysis workflows.

Health Economics & Implementation

Conduct comprehensive health economic evaluation to estimate costeffectiveness, NHS impact, and potential reduction in unplanned interventions, CVC insertions, and hospital admissions.
Co-design implementation pathways with clinicians, dialysis nurses, and
patients, ensuring usability, acceptability, and readiness for NHS procurement
and regulatory approval (MHRA/UKCA).

We are currently looking to start this next Phase of the Project in the 2nd half of 2026 once all partners are in place.

MGE